FDA Says No to Emergency Use of Lenzilumab in Hospitalized COVID-19 Patients
Lenzilumab is an investigational anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody.
Respiratory Diseases/Disorders
Albuterol/Budesonide Fixed-Dose Combo Looks Promising in Asthma Trials
The combination therapy significantly reduced the risk of severe exacerbations and improved lung function.
FDA Grants Fast Track Status to mRNA Respiratory Syncytial Virus Vaccine Candidate
mRNA-1345 is a vaccine candidate against RSV that utilizes the same lipid nanoparticle as Moderna’s authorized COVID-19 vaccine.
Aviptadil Gets Orphan Drug Status for Sarcoidosis
RLF-100 (aviptadil) is an inhaled, synthetic formulation of vasoactive intestinal peptide (VIP) for the treatment of sarcoidosis.
Nucala Approved for Chronic Rhinosinusitis With Nasal Polyps
The approval was based on data from the phase 3 SYNAPSE study that evaluated mepolizumab as an add-on maintenance treatment in over 400 adults with CRSwNP.
RSV and Parainfluenza Increase Hospitalization Risk in HIV-Exposed Infants
As HIV-exposed, uninfected infants have higher rates of morbidity and mortality than HIV-unexposed uninfected infants, a study was conducted to analyze whether particular infections or immune responses contribute to hospitalization.
Tezepelumab Gets Priority Review for Severe Asthma
The BLA submission included data from the pivotal phase 3 NAVIGATOR trial that assessed tezepelumab in 1061 patients with severe, uncontrolled asthma.
Anaphylaxis Risk Compared for Monoclonal Antibodies Used for Severe Asthma
Data mining resulted in 2006 reports of anaphylaxis related to the use of 5 mAbs.
Aquagenic Wrinkling of Palms Strongly Linked to Cystic Fibrosis Diagnosis
Investigators studied a test of the brief immersion to water of the hands for its value as an initial screening tool for the diagnosis of cystic fibrosis.
Generic Version of Perforomist Now Available
The first authorized generic version of Perforomist® (formoterol fumarate inhalation solution; Mylan Specialty L.P.) 20mcg/2mL has been made available by Teva Pharmaceuticals.
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